A number of devices are known for securing medical conduits to the limb of a patient. These devices typically include a primary strap which is adjustably secured around the limb of a patient, and a secondary strap, attached to the primary strap, which engages and secures the medical conduit in place.
One often-performed medical procedure requiring the use of a medical conduit holder is trans-urethral resection of the prostate (TURP), which is performed to relieve lower urinary tract obstructions. During the TURP procedure, a large Foley catheter with a 30-mL (milliliter) balloon is placed in the urethra to tamponade the surgical area and to drain the bladder. Active bleeding from the vascular prostatic tissue may continue for 24 to 48 hours, requiring continuous or intermittent irrigation to maintain catheter patency (flow). It can, therefore, be appreciated that catheter stability in such a procedure is very important, as movement or pulling of the catheter may cause the balloon to dislodge and block the flow of blood from the bladder. Other procedures, such as the Radical Perineal Prostatectomy (RPP), may require a Foley catheter to remain in place within the bladder for two weeks, or more, with little or no movement of the catheter until removal from the patient.
One commercially-successful device utilized to secure a conduit, such as a Foley catheter, is disclosed in U.S. Pat. No. 4,445,894 to Kovacs ('894 patent). The device includes a primary strap which is configured to be fastened around a limb of a patient, and a secondary strap which secures the medical conduit in place. The primary strap includes a stretchable section and a non-stretchable section having Velcro.TM.-type loops. The secondary strap has Velcro.TM.-type hooks for attachment to the non-stretchable looped section of the primary strap. The secondary strap may be a single piece of material which is sewn at an angle with respect to the primary strap. The secondary strap is sewn transversely down the center, so as to divide it in half, with the hooked surfaces of the two halves facing upwardly, away from the looped surface of the primary strap. The two halves of the secondary strap (on opposite sides of the stitching) are adapted to be looped over the medical conduit and hold the conduit in place by engagement of the hooks of the secondary strap with the looped fabric of the primary strap (FIG. 1a). Alternately, the '894 patent discloses that the secondary strap may include two straps made of hooked, Velcro.TM.-type material, which are each approximately half the size of the single, secondary strap. When utilizing two half-straps, the two halves are each secured parallel to the primary strap and offset from each other, each strap being stitched to the primary strap along its inner edge (FIG. 1b). The two, separate halves of the secondary strap may then be looped over the medical conduit in the same fashion as described with respect to the single, secondary strap.
FIG. 1c illustrates another prior art device for securing medical conduits, such as Foley catheters, to a limb. This device has been sold by Dale Medical Products, Inc. of Plainville, Mass., under the name "Foley Catheter Holder", and product number 316. The device (110) illustrated in FIG. 1c includes a primary strap (116) made of a stretchable fabric and a rectangular base piece (136) of non-stretchable fabric having a looped surface, which is sewn to the primary strap. The piece (136) is sewn in the transverse (width direction) to the primary strap (116) along its two opposing short ends, and also in the middle, parallel to the two opposing short ends. The device further includes a secondary strap (118) made of non-stretchable, hooked, Velcro.TM.-type plastic material. The secondary strap includes a first rectangular portion (142) having an aperture (144) formed therethrough, and a second, elongated engagement portion (146) formed integrally with and narrower in width than the first portion. To attach the secondary strap to the platform, a transverse stitch (width direction) is sewn through the secondary strap, between the window and the engagement portion, such that the hooked surface of the secondary strap faces upwardly, away from the looped fabric surface of the platform. The secondary strap may alternatively/additionally be attached to the primary strap by stitching, so as to attach the center of the base piece to the primary strap. In use, the medical conduit is placed on the secondary strap, between the window and the engagement portion, adjacent the stitching. The engagement portion is then looped over the medical conduit and through the window of the secondary strap, such that the hooked surface of the engagement portion contacts the looped fabric surface of the platform in order to secure the engagement portion to the platform. The first rectangular portion is then likewise looped over the medical conduit, such that the hooked surface of the rectangular portion contacts the looped fabric surface of the base piece. The base piece may somewhat limit the lengthwise stretchability of the primary strap along the side edges where the base piece is sewn, but does not eliminate the lengthwise stretchability under the base piece where the base piece is not sewn.
Although the aforementioned prior art devices have been successfully used to secure a catheter to the limb of a patient, in certain circumstances the catheter may become loose, especially if the primary strap is repositioned on the patient. For example, repositioning of Dale's 316 device described above, may cause buckling of the base piece (FIG. 1c), resulting in movement of the catheter. In certain procedures, such as TURP, any movement is undesirable.
There is therefore a need for a device which will very securely hold a medical conduit, such as a Foley catheter, in position on the patient, even after repositioning of the device.